The State Board of Respiratory Care (the Board) is proposing amendments to N.J.A.C. 13:44F-3.3, concerning the delegation of certain respiratory care services to unlicensed persons, and to N.J.A.C. 13:44F-10.2 and 10.3, concerning continuing education requirements. The Board is also proposing a new rule at N.J.A.C. 13:44F-10.2A that will permit licensees to obtain continuing education credit for successful completion of a Board-approved performance-based competency assessment.

Currently, N.J.A.C. 13:44F-3.3(d) provides that a licensed respiratory care practitioner may delegate certain tasks to unlicensed persons. Unlicensed persons may process, clean and sterilize basic respiratory equipment; maintain and handle oxygen, specialty gas cylinders and oxygen concentrators; and set up, test, exchange and demonstrate equipment related to basic respiratory delivery systems. The rule, however, prohibits unlicensed persons from setting up, testing, exchanging or demonstrating mechanical ventilators and positive pressure equipment. The Board has determined that amendments to subsection (d) are necessary to further clarify the types of activities that may be delegated to unlicensed persons.

The Board is proposing to amend N.J.A.C. 13:44F-3.3(d)1 and 2 to provide that unlicensed persons may disassemble, clean, disinfect, sterilize, assemble and deliver respiratory equipment; they may also perform oxygen checks and charges in connection with the maintenance and handling of oxygen, specialty gas cylinders and oxygen concentrators. The Board is proposing to delete N.J.A.C. 13:44F-3.3(d)3, which provides that an unlicensed assistant may set up, test, exchange and demonstrate equipment related to basic respiratory delivery systems. The proposed amendments to N.J.A.C. 13:44F-3.3(d)1 and 2 will continue to permit unlicensed assistants to set up, test and exchange such equipment. However, demonstration of such equipment by unlicensed assistants will no longer be permissible. The Board notes that it originally included "demonstrating" in the list of permissible tasks in N.J.A.C. 13:44F-3.3(d) in order to permit unlicensed assistants to explain to patients how basic respiratory equipment works. The Board, however, is concerned that this provision may be misinterpreted as authorizing unlicensed assistants to provide instruction to patients on proper use of the equipment, a function directly related to patient care and one that the Board believes must be performed only by licensed respiratory care practitioners.

The Board is also proposing to delete the prohibition contained in N.J.A.C. 13:44F-3.3(d)3i. The Board believes that unlicensed persons may set up, test and exchange mechanical ventilators or positive pressure equipment, in light of amendments the Board is proposing to N.J.A.C. 13:44F-3.3(e). The proposed amendments to subsection (e) require a licensed respiratory care practitioner who has delegated tasks to an unlicensed person to assess the assembly and operation of the respiratory equipment prior to use on a patient. The licensee must document this assessment and retain such documentation for at least three years. The Board believes that this requirement to assess assembly and operation, combined with the existing requirement in N.J.A.C. 13:44F-3.3(d) that prohibits unlicensed persons from providing direct patient care, will help ensure that licensed respiratory care practitioners continue to be directly responsible for patient care.

The Board believes that the proposed amendments to N.J.A.C. 13:44F-3.3 will help clarify what tasks may be delegated to unlicensed persons, as well as clarify a licensee's continuing obligation to ensure that such tasks have been properly performed, so as to safeguard patient health, safety and welfare.

The Board is also proposing amendments to its continuing education requirements to provide licensees with additional opportunities to obtain continuing education credit. The Board notes that it is not proposing any amendments to the number of continuing education credits that licensees must obtain. Licensees will continue to be required to obtain 30 continuing education credits in each biennial renewal period under the requirements of N.J.A.C. 13:44F-10.1. The Board is proposing to amend N.J.A.C. 13:44F-10.2(a)1, in order to add courses approved by the American Medical Association and the American Nursing Association to the list of courses that licensees may take for continuing education credit. The Board is also proposing to amend N.J.A.C. 13:44F-10.2 to add a new provision at (a)2 that will permit licensees to obtain continuing education credit for completing advanced credentialing examinations approved for continuing education credit by the National Board for Respiratory Care or the American Association for Respiratory Care. Licensees may claim one continuing education credit for each examination credit awarded by the respective organization. The Board believes that the amendments to paragraphs (a)1 and new paragraph (a)2 will provide licensees with added flexibility to help them meet their continuing education obligations.

Consistent with its desire to make it easier for licensees to obtain continuing education credit, and cognizant of the growing interest among licensed respiratory care practitioners to obtain continuing education through on-line or distance learning courses, the Board is proposing to amend recodified N.J.A.C. 13:44F-10.2(a)6 to increase the number of credits that licensees may obtain in such courses from 15 to 20 per biennial renewal period. The Board is also proposing to amend N.J.A.C. 13:44F-10.2(b) to permit licensees to obtain one-half credit hour of continuing education for 25 minutes of instruction after the first credit hour increment has been obtained. The proposed amendment would allow a licensee to claim, for example, one and one-half credits of continuing education for a course or program lasting 75 minutes.

The Board is also proposing a new rule at N.J.A.C. 13:44F-10.2A to provide licensees with an additional avenue to obtain continuing education credit. The proposed new rule will permit licensees to obtain credit for successful completion of a Board-approved performance-based competency assessment (PBCA). The PBCA must be administered in a licensed healthcare facility or by a licensed healthcare entity that provides respiratory care services; must include the presentation of materials and objectives, procedure demonstration by licensee attendees; and must include a written examination certified by the healthcare facility or entity's director of respiratory care. In the case of a healthcare entity that does not have a director of respiratory care, the PBCA must be administered by the entity's medical director. The PBCA may include only those clinical respiratory procedures within the scope of respiratory care practice provided by the healthcare facility or entity.

Under proposed new rule N.J.A.C. 13:44F-10.2A, the director of respiratory care must submit an application for Board approval of the PBCA at least 60 days prior to the administration of the assessment. The application must include the name of the healthcare facility or entity and the director of respiratory care, the name and qualifications of the PBCA presenter, and a description of the competency covered and the objectives [page=1332] to be achieved by the PBCA. The submission must also include copies of the written examination and the PBCA attendee evaluation form. The director of respiratory care must provide licensee attendees of the PBCA with a certificate of completion.

The PBCA must be least one instructional hour, or 50 minutes in length. The hour must include material presentation, procedure demonstration and examination. One continuing education credit will be awarded for each Board-approved PBCA to a maximum of six credits per biennial renewal period. The proposed new rule, however, provides that when the presentation of materials and objectives, procedure demonstration and written examination for a single topic is less than one instructional hour, two topics may be combined in one PBCA for Board approval. A Board-approved PBCA, however, may not include more than two topics. The proposed new rule also permits a PBCA to be administered by a healthcare entity, other than a licensed healthcare facility, provided the entity offers respiratory care services. In such cases, the PBCA must be certified by the healthcare entity's director of respiratory care or medical director.

The proposed new rule requires the director of respiratory care and all licensee attendees to maintain documentation of successful completion of the PBCA for four years from the date of completion, consistent with the Board's general continuing education document retention requirements set forth in N.J.A.C. 13:44F-10.3(a).

The Board is also proposing new N.J.A.C. 13:44F-10.3(c) to clarify for licensees that failure to complete continuing education requirements may result in the imposition of penalties and/or license suspension by the Board.

The Board has provided a 60-day comment period for this notice of proposal. Therefore, this notice is excepted from the rulemaking calendar requirement pursuant to N.J.A.C. 1:30-3.3(a)5.

Social Impact

The Board believes that the proposed amendments to N.J.A.C. 13:44F-3.3 may have a positive impact upon licensees and their unlicensed assistants by further clarifying what tasks may be delegated to unlicensed persons and the obligations that are imposed on delegating licensees. The Board believes that the proposed amendments may also have a positive impact upon patients by helping to ensure that licensed practitioners of respiratory care retain responsibility for direct patient care by requiring licensees who delegate tasks to unlicensed persons to assess and document the proper operation of all respiratory care equipment prior to patient use.

The Board believes that the proposed amendments to N.J.A.C. 13:44F-10.2 and proposed new rule N.J.A.C. 13:44F-10.2A may also have a positive impact upon licensed respiratory care practitioners by providing licensees with additional sources of continuing education to satisfy their continuing education obligations.

Economic Impact

The Board does not believe that the proposed amendments to the delegation requirements in N.J.A.C. 13:44F-3.3 will have any economic impact upon licensed respiratory care practitioners. The Board does not believe that the proposed amendments to N.J.A.C. 13:44F-10.2 and proposed new rule N.J.A.C. 13:44F-10.2A will have an economic impact upon licensees because, although additional sources of continuing education will now be available to licensees, the total number of required continuing education credits remains unchanged. But the Board believes that the proposed amendment to N.J.A.C. 13:44F-10.2(b), which will allow licensees to claim one-half credit for 25 minutes of instruction after completing the first credit hour of a course, may allow licensees to take fewer courses to satisfy the 30 credit requirement, possibly resulting in a cost savings.

Federal Standards Statement

A Federal standards analysis is not required because the proposed amendments and new rule are governed by N.J.S.A. 45:14E-1 et seq., and are not subject to any Federal standards or requirements.

Jobs Impact

The Board does not believe that the proposed amendments and new rule will result in an increase or decrease in the number of jobs in the State.

Agriculture Industry Impact

The proposed amendments and new rule will have no impact on the agriculture industry in the State.

Regulatory Flexibility Statement

Currently, the Board licenses approximately 3,352 respiratory care practitioners. If Board licensees are considered "small businesses," within the meaning of the Regulatory Flexibility Act, N.J.S.A. 52:14B-16 et seq., then the following analysis applies. The proposed amendments and new rule will not impose any reporting requirements, but will impose various recordkeeping and compliance requirements on licensed respiratory care practitioners. Those requirements are discussed in the Summary above.

No additional professional services will be needed to comply with the proposed amendments and new rule. The cost of compliance with the proposed amendments and new rule are discussed in the Economic Impact statement above. The Board believes that the proposed amendments and new rule should be uniformly applied to all licensed respiratory care practitioners in order to ensure the health, safety and welfare of the general public in the provision of respiratory care services by such individuals and, therefore, no differing compliance requirements for any businesses are provided based upon size.

Smart Growth Impact

The Board does not believe that the proposed amendments and new rule will have any impact upon the achievement of smart growth or upon the implementation of the State Development and Redevelopment Plan.

Housing Affordability Impact

The proposed amendments and new rule will have an insignificant impact on affordable housing in New Jersey and there is an extreme unlikelihood that the rules would evoke a change in the average costs associated with housing because the proposed amendments and new rule concern the practice of respiratory care.

Smart Growth Development Impact

The proposed amendments and new rule will have an insignificant impact on smart growth and there is an extreme unlikelihood that the rules would evoke a change in housing production in Planning Areas 1 or 2 or within designated centers under the State Development and Redevelopment Plan in New Jersey because the proposed amendments and new rule concern the practice of respiratory care.

i. An assistant shall not be permitted to set up, test, exchange or demonstrate mechanical ventilators or positive pressure equipment, such as continuous positive airway pressure and bi-level positive airway pressure devices, with or without artificial airways, in use continuously or intermittently. For purposes of this section, the term "exchange" does not mean delivery, and this section shall not preclude an unlicensed assistant from delivering such equipment to a patient's home.]

(e) A licensed respiratory care practitioner shall be responsible for any activities [which] that an assistant performs pursuant to (d) above[.] and shall assess and document proper assembly and operation of all respiratory equipment prior to use on a patient. Such documentation shall be retained for a period of three years.

(a) The following are acceptable sources of continuing education , [programs, courses, seminars and articles, as long as the programs, courses, seminars or articles] provided the subject matter fall s within the content areas set forth in N.J.A.C. 13:44F-10.1(c):

1. Successful completion of programs, courses or seminars offered or approved by the New Jersey Society for Respiratory Care , [or] the American Association for Respiratory Care , the American Medical Association or the American Nursing Association : one continuing education credit for each course credit awarded;

2. Successful completion of an advanced credentialing examination approved for continuing education credit by the National Board for Respiratory Care or the American Association for Respiratory Care: one continuing education credit for each examination credit awarded;

Recodify existing 2.-4. as 3.-5. (No change in text.)

[5.] 6. Successful completion of videotaped, Internet[,] and other distance learning courses, approved by one of the organizations listed in (a)1 above, with verification by the course provider that the course was monitored and successfully completed by the licensee: one continuing education credit for each course credit awarded with a maximum of [15] 20 credits per biennial licensure period.

(b) A licensee shall receive one continuing education credit for each hour of attendance at programs, courses and seminars approved by one of the organizations listed in (a)1 above. Credit shall not be granted for courses that are less than one instructional hour long. For purposes of this subchapter, an "instructional hour" represents a 60-minute clock hour with no less than 50 minutes of content within the hour. Programs may include one 10-minute break for each instructional hour. One-half credit hour of continuing education may be earned for 25 minutes of instruction or participation after the first credit hour increment has been earned.

(a) A licensee may obtain continuing education credit for successful completion of a Board-approved performance-based competency assessment (PBCA) administered in a licensed healthcare facility, consistent with the following requirements:

1. The PBCA shall include the presentation of materials and objectives, procedure(s) demonstration by licensee attendees and a written examination certified by the healthcare facility's director of respiratory care. For purposes of this section, a "director of respiratory care" means a respiratory care practitioner licensed in the State of New Jersey who is responsible for the activities of all respiratory care practitioners employed by the healthcare facility, including oversight for the policies and procedures that guide respiratory care practice in the healthcare facility;

2. The PBCA shall include only clinical respiratory procedures within the scope of practice of the healthcare facility's department of respiratory care;

3. The director of respiratory care shall submit an application for Board approval of the PBCA at least 60 days prior to the administration of the PBCA. The application shall include: the name of the healthcare facility, the name of the director of respiratory care, the name and qualifications of the PBCA presenter, a description of the competency covered and the objectives to be achieved by the PBCA, a copy of the written examination and a copy of the PBCA attendee evaluation form or its equivalent;

4. The director of respiratory care shall provide licensee attendees of the PBCA with a certificate of completion, which shall include the title of the PBCA, the date the PBCA was completed and the number of continuing education credits awarded for completion of the PBCA; and

5. The PBCA shall be at least one instructional hour in length. For purposes of this section, an "instructional hour" means no less than 50 minutes of material presentation, procedure(s) demonstration and examination. One continuing education credit shall be awarded for each Board-approved PBCA to a maximum of six credits per biennial registration period;

i. The Board shall not approve a PBCA that is less than one instructional hour in length, except that when the presentation of materials and objectives, procedure(s) demonstration and written examination for a single topic is less than one instructional hour, two topics may be combined in one PBCA for Board approval. A Board-approved PBCA shall include no more than two topics.

(b) A PBCA may be administered by a healthcare entity, other than a licensed healthcare facility, that provides respiratory care services, provided the PBCA is certified by the healthcare entity's director of respiratory care. If the healthcare entity does not have a director of respiratory care, the entity's medical director shall certify the PBCA. The entity's director of respiratory care or medical director shall ensure compliance with all requirements of this section.

(c) The director of respiratory care or the medical director and all licensee attendees of the PBCA shall maintain documentation of successful completion of the PBCA for four years from the date of completion consistent with the requirements of N.J.A.C. 13:44F-10.3(a).